ObesitySWIFTNCT04174755
Semaglutide's Efficacy in Achieving Weight Loss for Those With HIV
A study testing Semaglutide Injectable Product in people with Obesity and HIV-1-infection, run by University College Dublin at 1 site in Ireland.
Trial summary
The prevalence of obesity is rising worldwide, both in low- and high-income countries, including people with HIV (PWH). Semaglutide's efficacy in achieving weight loss in obese PWH is still unexplored. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, HIV-1-infection
- What is being tested?
- Semaglutide Injectable Product
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteIreland
- Study dates
- 22 Jun 2022to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be over 18 years old
- Be HIV-1 antibody positive as determined by a positive 4th generation Ag/Ab ELISA assay
- Be stable on ART with a viral load suppressed <40 copies/mL for a minimum of 2 years
- Have a CD4 count ≥200 cells/mm3 for a minimum of 1 year
- Have a BMI ≥30kg/m2 or have a BMI ≥27kg/m2 and hypertension, dyslipidaemia or type 2 diabetes mellitus
- Understand the study procedures, be able to comply with the study procedures, and voluntarily agree to participate by giving written informed consent for the trial
Who cannot join
- Subjects unable to comply with the study protocol or unable to self-administer subcutaneous semaglutide
- History of obesity induced by other endocrine disorders: hypothyroidism, Cushing's syndrome, primary and secondary hypogonadism, hypothalamic disorders, polycystic ovary syndrome, insulinoma
- History of obesity induced by use of anti-psychotic medications known to be associated with weight gain (i.e. olanzapine, clozapine).
- Treatment with GLP-1 receptor agonists (including liraglutide, semaglutide or exenatide), dipeptidyl peptidase-4 (DPP-4) inhibitors or insulin within the last 3 months (including saxagliptin, linagliptin, sitagliptin)
- History of severe renal impairment, as defined by a baseline creatinine clearance <30ml/min
- Individuals with a diagnosis of HIV-associated lipoatrophy/lipodystrophy, based on physician's assessment
Show all 16Show fewer
- Individuals with severe hepatic impairment (Child Pugh score >9)
- Subjects with active hepatitis B infection (defined as hepatitis B sAg positive) or hepatitis C (defined as hepatitis C Ab and RNA positive) co-infection
- Any active illness (including AIDS-defining illness) which in the opinion of the investigator precludes participation in the study
- History of cancer (apart from treated Kaposi's Sarcoma) and/or receiving chemotherapy or radiotherapy
- Active illicit intravenous drug use
- Subjects concurrently enrolled in another clinical trial of an investigational medicinal product.
- The investigator may decide that a subject cannot proceed in the study if there is any relevant other abnormal results in the screening assessments
- Subjects with any known or suspected hypersensitivity to semaglutide or any of the excipients of semaglutide
- Subjects on another medicinal product prescribed primarily for weight loss e.g. orlistat (see prohibited/cautioned concomitant medications/therapies section)
- For female subjects: pregnancy or breastfeeding at screening, planning future pregnancies or unwilling to take measures to avoid pregnancy for the duration of the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ireland1 site, 1 recruiting
- Recruiting
Mater Misericordiae University Hospital
Dublin, Dublin, D07 R2WY
Aoife Cotter, PhD, aoife.cotter@ucd.ie
About this study
The prevalence of obesity is rising worldwide, both in low- and high-income countries, including people with HIV (PWH). Semaglutide's efficacy in achieving weight loss in obese PWH is still unexplored. The aim of this study is to assess the efficacy and safety of semaglutide in achieving greater weight loss compared to diet and excercise alone in obese PWH and to explore the effect of semaglutide on the immune function, markers of immune activation, viral reservoir, markers of glucose and lipid metabolism and gut microbiome.
Read the detailed description
A randomised, controlled, parallel-group, open-label study comparing treatment with the GLP-1 analogue semaglutide in combination with lifestyle interventions to lifestyle interventions alone in obese PWH.
The study will enroll HIV-1 infected patients ≥ 18 years with BMI ≥30kg/m2 or BMI ≥27kg/m2 and hypertension, dyslipidaemia or type 2 diabetes mellitus.
Primary objective: To assess the efficacy of semaglutide as an adjunct to diet and exercise in achieving greater weight loss in obese PWH as compared to diet and exercise alone.
Secondary objectives:
- To explore the effect of semaglutide on markers of immune function and HIV viral reservoirs in obese PWH.
- To explore the effect of semaglutide on markers of glucose and lipid metabolism in obese PWH.
- To explore the effect of semaglutide on markers of inflammation and gut microbial translocation in obese PWH.
- To assess the safety of semaglutide in obese PWH on stable ART.
- Conditions
- Obesity, HIV-1-infection
- Being tested
- Semaglutide Injectable Product, Standard of care
- Keywords
- obesity, HIV, weight loss, GLP-1 analogue, immune activation, viral reservoir, gut microbiome
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semaglutide Injectable ProductDrug
Also called Ozempic
Semaglutide 0.25 mg subcutaneously once weekly for 4 weeks, then Semaglutide 0.5 mg subcutaneously once weekly for 4 weeks, then Semaglutide 1 mg subcutaneously once weekly for 20 weeks. Total treatment duration 28 weeks.
Standard of careBehavioural
Also called Diet and exercise
Diet and exercise advice for 40 weeks
| Study group | Role | What they receive |
|---|---|---|
| Semaglutide 0.25/0.5/1 mg plus standard of care | Experimental | Not described Receives: Drug: Semaglutide Injectable Product; Behavioral: Standard of care |
| Standard of care alone | Other | Not described Receives: Behavioral: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in total body weight (in Kg)
Between-group differences in percent change from baseline to week 28 in total body weight
Measured: 28 weeks
Secondary outcomes (9)
Proportion of subjects not achieving 5% weight loss from baseline to week 16
Between-group differences in number of subjects who do not achieve a 5% weight loss (in Kg) from baseline to week 16
Measured: 16 weeks
Changes in numbers and function of immune cell subsets
Between-group differences in percent change from baseline in numbers and functions of immune cells subsets (NK cells, MAIT cells, T-cells and Monocytes) as assessed through flow cytometry in a single assay
Measured: 40 weeks
Changes in quantified viral reservoir in peripheral blood mononuclear cells (PBMCs)
Between-group differences in percent change from baseline in HIV pro-viral DNA and cell-associated RNA (CA-RNA), measured in PBMCs (copies/mL)
Measured: 40 weeks
Changes in gut microbiome composition in stool samples
Between-group differences in percent change from baseline in gut microbiome composition (% prevalence of different microbial species) as assessed through molecular techniques in stool samples
Measured: 40 weeks
Changes in parameters of glucose metabolism in blood samples
Between-group differences in percent change from baseline in blood glucose levels (in mmol/L), HbA1c (in mmol/mol) and insulin levels (in pmol/L)
Measured: 40 weeks
Changes in parameters of lipid metabolism
Between-group differences in percent change from baseline in lipid profile: total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides (all in mmol/L)
Measured: 40 weeks
Proportion of subjects reporting any adverse event
Between-group differences in the number of subjects reporting any type of adverse event, including serious adverse events and suspected unexpected serious adverse reactions
Measured: 40 weeks
Changes in bone mineral density (BMD) and total body composition
Between-group differences in percent change from baseline in lumbar spine and hip BMD and total body composition (% fat mass and lean mass) as assessed through DXA scan
Measured: 40 weeks
Changes in liver stiffness
Between-group differences in percent change from baseline in liver stiffness (measured in kPa) as assessed thourgh liver elastography
Measured: 40 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2019
- Study start22 Jun 2022
- Primary completionJan 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College Dublin
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen, Rush University Medical Center
- Responsible party
- Principal investigator, Patrick Mallon, University College Dublin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04174755
- Sponsor's protocol ID
- SWIFT Study
- Acronym
- SWIFT
- Status last verified
- Apr 2026
- First submitted
- 6 Nov 2019
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
O'Sullivan L, Savinelli S, O'Hare S, Holden S, McHugh C, Mallon P, Doran P. An enhanced participant information leaflet and multimedia intervention to improve the quality of informed consent to a randomised clinical trial enrolling people living with HIV and obesity: a protocol for a Study Within A Trial (SWAT). Trials. 2022 Jan 17;23(1):50. doi: 10.1186/s13063-021-05979-y.
PubMed 35039057
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Semaglutide's Efficacy in Achieving Weight Loss for Those With HIV
- ClinicalTrials.gov ID
- NCT04174755
- Acronym / sponsor ID
- SWIFT / SWIFT Study
- Conditions
- Obesity, HIV-1-infection
- Keywords
- obesity, HIV, weight loss, GLP-1 analogue, immune activation, viral reservoir, gut microbiome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University College DublinUniversity, hospital or other
- Collaborators
- University of Copenhagen, Rush University Medical Center
- Study start
- 22 Jun 2022 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 22 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The prevalence of obesity is rising worldwide, both in low- and high-income countries, including people with HIV (PWH). Semaglutide's efficacy in achieving weight loss in obese PWH is still unexplored. The aim of this study is to assess the efficacy and safety of semaglutide in achieving greater weight loss compared to diet and excercise alone in obese PWH and to explore the effect of semaglutide on the immune function, markers of immune activation, viral reservoir, markers of glucose and lipid metabolism and gut microbiome.
Detailed description
A randomised, controlled, parallel-group, open-label study comparing treatment with the GLP-1 analogue semaglutide in combination with lifestyle interventions to lifestyle interventions alone in obese PWH.
The study will enroll HIV-1 infected patients ≥ 18 years with BMI ≥30kg/m2 or BMI ≥27kg/m2 and hypertension, dyslipidaemia or type 2 diabetes mellitus.
Primary objective: To assess the efficacy of semaglutide as an adjunct to diet and exercise in achieving greater weight loss in obese PWH as compared to diet and exercise alone.
Secondary objectives:
- To explore the effect of semaglutide on markers of immune function and HIV viral reservoirs in obese PWH.
- To explore the effect of semaglutide on markers of glucose and lipid metabolism in obese PWH.
- To explore the effect of semaglutide on markers of inflammation and gut microbial translocation in obese PWH.
- To assess the safety of semaglutide in obese PWH on stable ART.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Semaglutide 0.25/0.5/1 mg plus standard of care | Experimental | Drug: Semaglutide Injectable Product, Behavioral: Standard of care |
| Standard of care alone | Other | Behavioral: Standard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Be over 18 years old
- Be HIV-1 antibody positive as determined by a positive 4th generation Ag/Ab ELISA assay
- Be stable on ART with a viral load suppressed <40 copies/mL for a minimum of 2 years
- Have a CD4 count ≥200 cells/mm3 for a minimum of 1 year
- Have a BMI ≥30kg/m2 or have a BMI ≥27kg/m2 and hypertension, dyslipidaemia or type 2 diabetes mellitus
Key exclusion criteria (16 listed)
- Subjects unable to comply with the study protocol or unable to self-administer subcutaneous semaglutide
- History of obesity induced by other endocrine disorders: hypothyroidism, Cushing's syndrome, primary and secondary hypogonadism, hypothalamic disorders, polycystic ovary syndrome, insulinoma
- History of obesity induced by use of anti-psychotic medications known to be associated with weight gain (i.e. olanzapine, clozapine).
- Treatment with GLP-1 receptor agonists (including liraglutide, semaglutide or exenatide), dipeptidyl peptidase-4 (DPP-4) inhibitors or insulin within the last 3 months (including saxagliptin, linagliptin, sitagliptin)
- History of severe renal impairment, as defined by a baseline creatinine clearance <30ml/min
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Semaglutide Injectable ProductAlso: OzempicSemaglutide 0.25 mg subcutaneously once weekly for 4 weeks, then Semaglutide 0.5 mg subcutaneously once weekly for 4 weeks, then Semaglutide 1 mg subcutaneously once weekly for 20 weeks. Total treatment duration 28 weeks. | Drug | Semaglutide 0.25/0.5/1 mg plus standard of care |
| Standard of careAlso: Diet and exerciseDiet and exercise advice for 40 weeks | Behavioural | Semaglutide 0.25/0.5/1 mg plus standard of care, Standard of care alone |
Primary outcome
Changes in total body weight (in Kg)
Time frame: 28 weeks
Between-group differences in percent change from baseline to week 28 in total body weight
9 secondary outcomes
Proportion of subjects not achieving 5% weight loss from baseline to week 16
Time frame: 16 weeks
Changes in numbers and function of immune cell subsets
Time frame: 40 weeks
Changes in quantified viral reservoir in peripheral blood mononuclear cells (PBMCs)
Time frame: 40 weeks
Changes in gut microbiome composition in stool samples
Time frame: 40 weeks
Changes in parameters of glucose metabolism in blood samples
Time frame: 40 weeks
Changes in parameters of lipid metabolism
Time frame: 40 weeks
Proportion of subjects reporting any adverse event
Time frame: 40 weeks
Changes in bone mineral density (BMD) and total body composition
Time frame: 40 weeks
Changes in liver stiffness
Time frame: 40 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Derived from this study: PubMed 35039057O'Sullivan L, Savinelli S, O'Hare S, Holden S, McHugh C, Mallon P, Doran P. An enhanced participant information leaflet and multimedia intervention to improve the quality of informed consent to a randomised clinical trial enrolling people living with HIV and obesity: a protocol for a Study Within A Trial (SWAT). Trials. 2022 Jan 17;23(1):50. doi: 10.1186/s13063-021-05979-y.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Semaglutide Injectable Product in people with Obesity and HIV-1-infection, run by University College Dublin at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stefano Savinelli, MD (+3532215014, stefano.savinelli1@ucd.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in total body weight (in Kg) (time frame: 28 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04174755, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.